MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE ROD APPROXIMATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	274655100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.Awaiting sample: a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not yet returned for evaluation.
Event or Problem Description
Attempting to reduce the rod into the mountaineer poly screw head, the rod reduction pistol device was used.The force applied resulted in the "tips" of the device to break.The tips were small and were unable to be readily retrieved.A final flat-plate x-ray was taken to ensure that they were not left behind in the patient.Upon x-ray review, the surgeon and radiologist confirmed not remaining pieces remained insitu.The surgeon theorized that the small loose pieces were most likely sucked into the suction bank.
Additional Manufacturer Narrative
Device was not returned for evaluation.A trend analysis was conducted.No emerging trends were found requiring further actions.Without the returned of the device we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ROD APPROXIMATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6831626
• Report Number: 1526439-2017-10725
• Device Sequence Number: 67833
• Product Code: LXH
• UDI-Device Identifier: 10705034193175
• UDI-Public: (01)10705034193175
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 274655100
• Device Lot Number: DC0105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1
• Patient Age: 46 YR